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Autologous regulatory T cells (Tregs) are a form of cell therapy in which a patient's own regulatory T cells are isolated, expanded ex vivo, and reinfused to modulate immune responses. Regulatory T cells are a specialized subpopulation of CD4+ lymphocytes characterized by the expression of FOXP3 and CD25. They play a critical role in maintaining immune tolerance and preventing autoimmune disease by suppressing effector immune responses through multiple mechanisms including secretion of immunoregulatory cytokines, metabolic disruption, cytolysis, and modulation of antigen-presenting cell function[1][2][5][7]. Autologous approaches use the patient’s own (autologous) cells to minimize risk of rejection or graft-versus-host disease[3][8]. Clinical trials have investigated their use for autoimmune diseases such as type 1 diabetes (T1D), systemic lupus erythematosus (SLE), Crohn’s disease, ulcerative colitis (UC), multiple sclerosis (MS), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), as well as for promoting tolerance in solid organ transplantation[6][8][9][10]. Early-phase clinical studies have demonstrated safety; efficacy is under ongoing investigation[6][8].
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